Phase 3
Completed N=2,624
Tiotropium+Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01431274 ↗
Enrolled (actual)
2,624
Serious AEs
14.8%
Results posted
Jul 2015
Primary outcomePrimary: Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169. — 0.133; 0.148; 0.139; 0.241 Litres — p=<0.0001
Summary
The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components ( tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169. |
0.133; 0.148; 0.139; 0.241; 0.256 | <0.0001 sig |
| PRIMARY Trough FEV1 Response on Day 170. |
0.054; 0.083; 0.065; 0.111; 0.136 | <.0001 sig |
| PRIMARY Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) |
38.366; 37.792; 37.907; 37.335; 36.674 | 0.0022 sig |
| SECONDARY Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) |
1.564; 1.690; 1.627; 1.980; 1.983 | 0.0019 sig |
| SECONDARY FEV1 AUC(0-3h) Response on Day 1 |
0.205; 0.148; 0.157; 0.226; 0.237 | 0.0067 sig |
| SECONDARY FEV1 AUC(0-3h) Response on Day 85 |
0.161; 0.176; 0.162; 0.271; 0.289 | <0.0001 sig |
| SECONDARY FEV1 AUC(0-3h) Response on Day 365 |
0.096; 0.116; 0.122; 0.214; 0.237 | <0.0001 sig |
| SECONDARY Trough FEV1 Response on Day 15. |
0.085; 0.101; 0.094; 0.132; 0.157 | <0.0001 sig |
| SECONDARY Trough FEV1 Response on Day 43 |
0.083; 0.097; 0.088; 0.120; 0.163 | <0.0001 sig |
| SECONDARY Trough FEV1 Response on Day 85 |
0.057; 0.077; 0.070; 0.128; 0.146 | <0.0001 sig |
| SECONDARY Trough FEV1 Response on Day 169 |
0.033; 0.047; 0.050; 0.094; 0.112 | <0.0001 sig |
| SECONDARY Trough FEV1 Response on Day 365 |
-0.000; 0.028; 0.036; 0.075; 0.099 | <0.0001 sig |
| SECONDARY FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 1 |
0.350; 0.277; 0.289; 0.400; 0.427 | 0.0017 sig |
| SECONDARY FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 85 |
0.247; 0.318; 0.275; 0.432; 0.469 | <0.0001 sig |
| SECONDARY FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 169 |
0.212; 0.279; 0.254; 0.386; 0.407 | <0.0001 sig |
| SECONDARY FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 365 |
0.172; 0.241; 0.221; 0.364; 0.377 | <0.0001 sig |
| SECONDARY Trough FVC Response on Day 15. |
0.149; 0.222; 0.220; 0.270; 0.296 | <0.0001 sig |
| SECONDARY Trough FVC Response on Day 43. |
0.150; 0.206; 0.213; 0.254; 0.318 | <0.0001 sig |
| SECONDARY Trough FVC Response on Day 85. |
0.077; 0.168; 0.144; 0.230; 0.265 | <0.0001 sig |
| SECONDARY Trough FVC Response on Day 170. |
0.093; 0.184; 0.169; 0.225; 0.246 | <0.0001 sig |
| SECONDARY Trough FVC Response on Day 365. |
0.014; 0.114; 0.108; 0.155; 0.191 | <0.0001 sig |
| SECONDARY FEV1 AUC(0-12h) Response in the Sub-set of Patients With 12-hour Pulmonary Function Test (PFT) on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) |
0.131; 0.109; 0.127; 0.202; 0.250 | <0.0001 sig |
| SECONDARY FEV1 AUC(0-24h) Response in the Sub-set of Patients With 12-h PFTs on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) |
0.108; 0.083; 0.100; 0.159; 0.206 | <0.0001 sig |
| SECONDARY FVC AUC(0-12h) Response in the Sub-set of Patients With 12-h PFTs on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) |
0.227; 0.180; 0.248; 0.356; 0.388 | 0.0002 sig |
| SECONDARY FVC AUC(0-24h) Response in Sub-set of Patients With 24-h PFTs on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) |
0.192; 0.141; 0.203; 0.297; 0.329 | 0.0008 sig |
| SECONDARY Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 85 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) |
38.832; 37.821; 37.822; 37.304; 36.691 | 0.0001 sig |
| SECONDARY Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 365 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) |
38.989; 37.609; 37.581; 37.553; 37.138 | 0.0014 sig |
| SECONDARY Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 43 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) |
1.453; 1.430; 1.408; 1.876; 2.048 | <0.0001 sig |
| SECONDARY Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 85 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) |
1.506; 1.698; 1.702; 1.925; 2.136 | <0.0001 sig |
| SECONDARY Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 365 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) |
1.411; 1.450; 1.736; 1.782; 2.058 | <0.0001 sig |
Eligibility Criteria
Inclusion criteria
- Diagnosis of chronic obstructive pulmonary disease.
- Relatively stable airway obstruction with post FEV1< 80% predicted normal and post FEV1/FVC <70%.
- Male or female patients, 40 years of age or older.
- Smoking history of more than 10 pack years.
Exclusion criteria
- Significant disease other than COPD
- Clinically relevant abnormal lab values.
- History of asthma.
- Diagnosis of thyrotoxicosis
- Diagnosis of paroxysmal tachycardia
- History of myocardial infarction within 1 year of screening visit
- Unstable or life-threatening cardiac arrhythmia.
- Hospitalization for heart failure within the past year.
- Known active tuberculosis.
- Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
- History of life-threatening pulmonary obstruction.
- History of cystic fibrosis.
- Clinically evident bronchiectasis.
- History of significant alcohol or drug abuse.
- Thoracotomy with pulmonary resection
- Oral ß-adrenergics.
- Oral corticosteroid medication at unstable doses
- Regular use of daytime oxygen therapy for more than one hour per day
- Pulmonary rehabilitation program in the six weeks prior to the screening visit
- Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
- Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA
- Pregnant or nursing women.
- Women of childbearing potential not using a highly effective method of birth control
- Patients who are unable to comply with pulmonary medication restrictions
Data sourced from ClinicalTrials.gov (NCT01431274). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.